Document 32017R0776

Commission Regulation (EU) 2017/776 of 4 May 2017 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance. )

Commission Regulation (EU) 2017/776 of 4 May 2017 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance. )

Commission Regulation (EU) 2017/776 of 4 May 2017 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance. )

amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (1), and in particular Article 37(5) thereof,

Whereas:

(1)

Table 3.1 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 contains the list of harmonised classification and labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to that Regulation.

(2)

Proposals for new, updated or deleted harmonised classification and labelling of certain substances have been submitted to the European Chemicals Agency (ECHA) pursuant to Article 37 of Regulation (EC) No 1272/2008. Based on the opinions on those proposals issued by the Committee for Risk Assessment of ECHA (RAC), as well as on the comments received from the parties concerned, it is appropriate to introduce, update or delete harmonised classification and labelling of certain substances.

(3)

The Acute Toxicity Estimates (ATE) are mainly used to determine the classification for human health acute toxicity of mixtures containing substances classified for acute toxicity. The inclusion of harmonised ATE values in the entries listed in Annex VI to Regulation (EC) No 1272/2008 would facilitate the harmonisation of the classification of mixtures and provide support for enforcement authorities. The ATE values harmonised in accordance with Article 37 should be added in the penultimate column of Table 3.1 of Part 3 of Annex VI to that Regulation. Pursuant to Article 38(1)(e) those values are to be mentioned in the opinions and decisions for harmonised classification. The title of the column of Table 3.1 of Part 3 as well as section 1.1.2.3 of Part 1 of Annex VI to Regulation (EC) No 1272/2008 should be amended consequently.

(4)

Compliance with the new harmonised classifications and the new provision on the ATE in section 1.1.2.3 of Part 1 of Annex VI to Regulation (EC) No 1272/2008 should not be required immediately, as a certain period of time will be necessary to allow suppliers to adapt the labelling and packaging of substances and mixtures to the new classifications and to sell existing stocks. That period of time will also be necessary to allow suppliers to adapt to and to comply with other legislative obligations resulting from the new harmonised classifications for substances such as those set out in Article 22(f) or Article 23 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2), those set out in Article 50 of Regulation (EU) No 528/2012 of the European Parliament and of the Council (3) or those set out in Article 44 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (4).

(5)

Table 3.2 of Annex VI to Regulation (EC) No 1272/2008, which lists the harmonised classification and labelling of hazardous substances based on the criteria set out in Council Directive 67/548/EEC (5), has been deleted with effect from 1 June 2017. For reasons of consistency, the references to Table 3.2 in Parts 1 and 3 of Annex VI to Regulation (EC) No 1272/2008 should be deleted with effect from the same date. For reasons of clarity, Table 3.1 of Annex VI to Regulation (EC) No 1272/2008 should become Table 3 and all references to Table 3.1 in that Annex should be changed accordingly.

(6)

Directive 67/548/EEC and Directive 1999/45/EC of the European Parliament and of the Council (6) have been repealed with effect from 1 June 2015. For reasons of consistency, the references to those Directives in the introductory part and in Parts 1 and 3 of Annex VI to Regulation (EC) No 1272/2008 should be deleted simultaneously with the changes regarding the references to Tables 3.1 and 3.2 of Annex VI to that Regulation with effect from 1 June 2017, which is the date provided for in Article 61(4) of Regulation (EC) No 1272/2008 before which mixtures which are classified, labelled and packaged in accordance with Directive 1999/45/EC and placed on the market before 1 June 2015 need not to be relabelled and repackaged in accordance with Regulation (EC) No 1272/2008.

(7)

Regulation (EC) No 1272/2008 should be amended accordingly.

(8)

In line with the transitional provisions of Regulation (EC) No 1272/2008 which allow the application of the new provisions at an earlier stage on a voluntary basis, suppliers should have the possibility of applying the new harmonised classifications and of adapting the labelling and packaging accordingly on a voluntary basis before the deadline for compliance.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133 of Regulation (EC) No 1907/2006,

HAS ADOPTED THIS REGULATION:

Article 1

Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this Regulation.

Article 2

1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2. This Regulation shall apply from 1 December 2018.

In the Annex, point (1), points (a), (b), (d), (e), (f), (g), (h), (i) and (j) of point (2) and points (a) and (b) of point (3) shall apply from 1 June 2017.

3. By way of derogation from paragraph 2, substances and mixtures may, before 1 December 2018, be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

(2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

(3) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

(4) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

(5) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 196, 16.8.1967, p. 1).

(6) Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 200, 30.7.1999, p. 1).

ANNEX

Annex VI to Regulation (EC) No 1272/2008 is amended as follows:

(1)

the introductory paragraphs are replaced by the following:

‘Part 1 of this Annex provides an introduction to the list of harmonised classification and labelling, including information listed for each entry and related classifications and hazard statements in Table 3.

Part 2 of this Annex lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling of substances at Union level.

Part 3 of this Annex lists hazardous substances for which harmonised classification and labelling have been established at Union level. In Table 3 the classification and labelling are based on the criteria in Annex I to this Regulation.’;

(2)

Part 1 is amended as follows:

(a)

the title of Section 1.1.2 is replaced by the following:

‘1.1.2. Information related to the classification and labelling of each entry in Table 3’;

Specific concentration limits (SCL), where different from the generic concentration limits given in Annex I for a certain category, are given in a separate column together with the classification concerned using the same codes as under 1.1.2.1.1. Also harmonised ATEs are listed in the same column of table 3. The SCLs and harmonised ATEs must be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance. When applying an ATE, the additivity formula as described in 3.1.3.6 of Annex I shall be used. Where no specific concentration limits are given in this Annex for a certain category, the generic concentration limits given in Annex I must be applied for the classification of substances containing impurities, additives or individual constituents or for mixtures. If harmonised ATE values are missing for acute toxicity the correct value has to be established by using the available data.

Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with reference to the total weight of the mixture.

In case an M-factor has been harmonised for substances classified as hazardous to the aquatic environment in the categories Aquatic Acute 1 or Aquatic Chronic 1, that M-factor is given in Table 3 in the same column as the specific concentration limits. In case an M-factor for Aquatic Acute 1 and an M-factor for Aquatic Chronic 1 have been harmonised, each M-factor shall be listed in the same line as its corresponding differentiation. Where a single M-factor is given in Table 3 and the substance is classified as Aquatic Acute 1 and Aquatic Chronic 1, that M-factor shall be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance for acute and long-term aquatic hazards using the summation method. Where no M-factor is given in Table 3, M-factor(s) based on available data for the substance shall be set by the manufacturer, importer or downstream user. For the setting and use of M-factors, see Section 4.1.3.5.5.5 of Annex I.’;

(c)

Section 1.1.3.1 is amended as follows:

(i)

Note E is deleted;

(ii)

Note K is replaced by the following:

‘Note K:

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 should apply. This note applies only to certain complex oil-derived substances in Part 3.’;

(iii)

Note P is replaced by the following:

‘Note P:

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7).

When the substance is not classified as a carcinogen at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 shall apply.

This note applies only to certain complex oil-derived substances in Part 3.’;

(iv)

Note S is replaced by the following:

‘Note S:

This substance may not require a label according to Article 17 (see Section 1.3 of Annex I) (Table 3).’;

(v)

in Note U, the title is replaced by the following:

‘Note U (Table 3):’;

(d)

Section 1.1.3.2 is amended as follows:

(i)

Note 1 is replaced by the following:

‘Note 1:

The concentration stated or, in the absence of such concentrations, the generic concentrations set out in this Regulation are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture.’;

(ii)

Note 8 is added as follows:

‘Note 8:

The classification as a carcinogen need not apply if it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 0,1 %.’;

(iii)

Note 9 is added as follows:

‘Note 9:

The classification as a mutagen need not apply if it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 1 %.’;

(e)

Section 1.1.4 is deleted;

(f)

The Title of Section 1.2 is replaced by the following:

‘1.2. Classifications and hazard statements in Table 3 arising from translation of classifications listed in Annex I to directive 67/548/EEC’;

(g)

Section 1.2.1 is replaced by the following:

‘1.2.1. Minimum classification

For certain hazard classes, including acute toxicity and STOT repeated exposure, the classification according to the criteria in Directive 67/548/EEC does not correspond directly to the classification in a hazard class and category under this Regulation. In these cases the classification in this Annex shall be considered as a minimum classification. This classification shall be applied if none of the following conditions are fulfilled:

—

the manufacturer or importer has access to data or other information, as specified in Part 1 of Annex I, that lead to classification in a more severe category compared to the minimum classification. Classification in the more severe category must then be applied,

—

the minimum classification can be further refined based on the translation table in Annex VII when the physical state of the substance used in the acute inhalation toxicity test is known to the manufacturer or importer. The classification as obtained from Annex VII shall then substitute the minimum classification indicated in this Annex if it differs from it.

Minimum classification for a category is indicated by the reference * in the column “Classification” in Table 3.

The reference * can also be found in the column “Specific Conc. Limits and M-factors and Acute Toxicity Estimates (ATE)” where it indicates that the entry concerned had specific concentration limits under Directive 67/548/EEC for acute toxicity. These concentration limits cannot be “translated” into concentration limits under this Regulation, especially when a minimum classification is given. However, when the reference * is shown, the classification for acute toxicity for this entry may be of special concern.’;

(h)

Section 1.2.2 is replaced by the following:

‘1.2.2. Route of exposure cannot be excluded

For certain hazard classes, e.g. STOT, the route of exposure should be indicated in the hazard statement only if it is conclusively proven that no other route of exposure can cause the hazard in accordance to the criteria in Annex I. Under Directive 67/548/EEC the route of exposure was indicated for classifications with R48 when there was data justifying the classification for this route of exposure. The classification under 67/548/EEC indicating the route of exposure has been translated into the corresponding class and category according to this Regulation, but with a general hazard statement not specifying the route of exposure as the necessary information is not available.

These hazard statements are indicated by the reference ** in Table 3.’;

(i)

Section 1.2.3 is replaced by the following:

‘1.2.3. Hazard statements for reproductive toxicity

Hazard statements H360 and H361 indicate a general concern for effects on fertility and/or development: “May damage/Suspected of damaging fertility or the unborn child”. According to the criteria, the general hazard statement can be replaced by the hazard statement indicating the specific effect of concern in accordance with Section 1.1.2.1.2. When the other differentiation is not mentioned, this is due to evidence proving no such effect, inconclusive data or no data and the obligations in Article 4(3) shall apply for that differentiation.

In order not to lose information from the harmonised classifications for fertility and developmental effects under Directive 67/548/EEC, the classifications have been translated only for those effects classified under that Directive.

These hazard statements are indicated by the reference *** in Table 3.’;

(j)

Section 1.2.4 is replaced by the following:

‘1.2.4. Correct classification for physical hazards could not be established

For some entries the correct classification for physical hazards could not be established because sufficient data are not available for the application of the classification criteria in this Regulation. The entry might be assigned to a different (also higher) category or even another hazard class than indicated. The correct classification shall be confirmed by testing.

The entries with physical hazards that need to be confirmed by testing are indicated by the reference **** in Table 3.’;

(3)

Part 3 is amended as follows:

(a)

the header of Part 3 is replaced by the following:

‘3.

PART 3: HARMONISED CLASSIFICATION AND LABELLING TABLE’;

(b)

the introductory paragraphs are deleted;

(c)

the title of Table 3.1 is replaced by the following:

‘Table 3

List of harmonised classification and labelling of hazardous substances’;

(d)

Table 3 is amended as follows:

(i)

the title of the penultimate column is replaced by ‘Specific Conc. Limits, M-factors and ATE’;